- Production Oversight : Supervise aseptic manufacturing, batch execution, and lyophilization .
- Compliance & Documentation : Ensure adherence to cGMP, SOPs, and regulatory guidelines; review BMRs, deviations, and CAPAs.
- Resource Management : Plan manpower, materials, and equipment utilization for smooth operations.
- Technical Leadership : Lead process validations, equipment qualifications, and technology transfers.
- Cross-Functional Coordination : Collaborate with QA, QC, Engineering, Warehouse, and R&D; for seamless production.
- Continuous Improvement : Implement process optimization, efficiency initiatives, and aseptic best practices.
- Audit Readiness : Prepare for internal/external audits and regulatory inspections.
Qualifications
- Graduate/Postgraduate in Pharmacy, Biotechnology, or related field.
- 7-15 years of experience in sterile injectable production (depending on Manager/AM level).
- Robust knowledge of aseptic techniques, regulatory compliance, and sterile facility operations.
- Leadership, problem-solving, and cross-functional collaboration skills.